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Osteoporosis

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Osteoporosis

Introduction

This pathway covers NICE guidance on osteoporosis in adults (18 years and older), including assessing the risk of fragility fracture and drug treatment for the primary and secondary prevention of osteoporotic fragility fractures.
Osteoporosis is a disease characterised by low bone mass and structural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture.
Fragility fractures are fractures that result from mechanical forces that would not ordinarily result in fracture (equivalent to a fall from a standing height or less), known as low-level (or 'low energy') trauma.
Reduced bone density is a major risk factor for fragility fractures. Other factors that may affect risk of fragility fractures include the use of oral or systemic glucocorticoids, age, sex, previous fractures and family history of osteoporosis. Because of increased bone loss after the menopause in women, and age-related bone loss in both women and men, the prevalence of osteoporosis increases markedly with age. As the longevity of the population increases, so will the incidence of osteoporosis and fragility fracture.
Fragility fractures occur most commonly in the spine (vertebrae), hip (proximal femur), and wrist (distal radius). They may also occur in the arm (humerus), pelvis, ribs and other bones. Major osteoporotic fractures are defined as fractures associated with low bone mineral density (BMD) and includes clinical spine, forearm, hip or shoulder fractures.
Osteoporotic fragility fractures can cause substantial pain and severe disability, often leading to a reduced quality of life. Hip and vertebral fractures are associated with decreased life expectancy. Hip fracture nearly always requires hospitalisation and can be fatal or permanently disabling. There are a number of therapies and treatments available for the prevention of fragility fractures in people who are thought to be at risk, or to prevent further fractures in those who have already had one or more fragility fractures.
Identifying who will benefit from preventative treatment is imprecise. A number of risk assessment tools are available to predict fracture incidence over a period of time, and these may be used to aid decision-making. This pathway provides guidance on the selection and use of risk assessment tools in the care of people who may be at risk of fragility fractures.

Quality standards

Quality statements

Effective interventions library

Successful effective interventions library details

Implementation

Service improvement and audit

These resources provide help with planning ahead for NICE guidance, understanding where you are now, and conducting improvement initiatives.

Pathway information

Patient-centred care

Patients and healthcare professionals have rights and responsibilities as set out in the NHS Constitution for England – all NICE guidance is written to reflect these. Treatment and care should take into account individual needs and preferences. People should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals. If the person is under 16, their family or carers should also be given information and support to help the child or young person to make decisions about their treatment. Healthcare professionals should follow the Department of Health's advice on consent. If someone does not have capacity to make decisions, healthcare professionals should follow the code of practice that accompanies the Mental Capacity Act and the supplementary code of practice on deprivation of liberty safeguards.
For young people moving between paediatric and adult services, care should be planned and managed according to the best practice guidance described in the Department of Health’s Transition: getting it right for young people.
Adult and paediatric healthcare teams should work jointly to provide assessment and services to young people. Diagnosis and management should be reviewed throughout the transition process, and there should be clarity about who is the lead clinician to ensure continuity of care.

Updates to this pathway

2 January 2014 Minor maintenance updates.
2 September 2013 The information about independent clinical risk factors has been removed from the section on denosumab in secondary prevention of osteoporotic fragility fractures in postmenopausal women on the 'Osteoporosis overview' path. The use of denosumab for the secondary prevention of osteoporotic fragility fractures in postmenopausal women (recommendation 1.2 of NICE technology appraisal guidance 204) does not depend on independent clinical risk factors.
14 May 2013 minor maintenance update.
25 April 2013 Minor update.
24 April 2013 Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for osteoporotic vertebral compression fractures (NICE technology appraisal guidance 279) added to a new node Treatment of vertebral compression fractures in the 'Osteoporosis overview' path.

Supporting information

Glossary

Bone mineral density.
Dual-energy X-ray absorptiometry.
Standard deviations.

People presenting in any healthcare setting

People presenting in any healthcare setting

Primary prevention of osteoporotic fragility fractures in postmenopausal women

Primary prevention of osteoporotic fragility fractures in postmenopausal women

Primary prevention of osteoporotic fragility fractures in postmenopausal women

Alendronate, etidronate, risedronate, raloxifene and strontium ranelate

This guidance relates only to treatments for the primary prevention of fragility fractures in postmenopausal women who have osteoporosis. Osteoporosis is defined by a T-scoreT-score relates to the measurement of bone mineral density (BMD) using central (hip and/or spine) DXA scanning, and is expressed as the number of standard deviations (SD) from peak BMD. of -2.5 SD or below on DXA scanning. However, the diagnosis may be assumed in women aged 75 years or older if the responsible clinician considers a DXA scan to be clinically inappropriate or unfeasible.
This guidance assumes that women who receive treatment have an adequate calcium intake and are vitamin D replete. Unless clinicians are confident that women who receive treatment meet these criteria, calcium and/or vitamin D supplementation should be considered.
This guidance does not cover the following:
  • The treatment of women who have sustained a clinically apparent osteoporotic fragility fracture (for recommendations for the treatment of women with a prior osteoporotic fragility fracture, see secondary prevention of osteoporotic fragility fractures in postmenopausal women in this pathway).
  • The use of alendronate, etidronate, risedronate, raloxifene or strontium ranelate for the primary prevention of osteoporotic fragility fractures in women with normal BMD or osteopenia (that is, women with a T-score between -1 and -2.5 SD below peak BMD).
  • The use of these drugs for the primary prevention of osteoporotic fragility fractures in women who are on long-term systemic corticosteroid treatment.
Alendronate is recommended as a treatment option for the primary prevention of osteoporotic fragility fractures in the following groups:
  • Women aged 70 years or older who have an independent clinical risk factor for fracture (see below) or an indicator of low BMD (see below) and who are confirmed to have osteoporosis (that is, a T-score of -2.5 SD or below). In women aged 75 years or older who have two or more independent clinical risk factors for fracture or indicators of low BMD, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible.
  • Women aged 65–69 years who have an independent clinical risk factor for fracture (see below) and who are confirmed to have osteoporosis (that is, a T-score of -2.5 SD or below).
  • Postmenopausal women younger than 65 years who have an independent clinical risk factor for fracture (see below) and at least one additional indicator of low BMD (see below) and who are confirmed to have osteoporosis (that is, a T-score of -2.5 SD or below).
  • When the decision has been made to initiate treatment with alendronate, the preparation prescribed should be chosen on the basis of the lowest acquisition cost available.
Risedronate and etidronate are recommended as alternative treatment options for the primary prevention of osteoporotic fragility fractures in postmenopausal women:
  • who are unable to comply with the special instructions for the administration of alendronate, or have a contraindication to or are intolerant of alendronate (as defined below) and
  • who also have a combination of T-score, age and number of independent clinical risk factors for fracture (see below) as indicated in the following table.
T-scores (SD) at (or below) which risedronate or etidronate is recommended when alendronate cannot be taken
Number of independent clinical risk factors for fracture
Age (years)
0
1
2
65–69
N/Aa
-3.5
-3.0
70–74
-3.5
-3.0
-2.5
75 or older
-3.0
-3.0
-2.5
a Treatment with risedronate or etidronate is not recommended.
If a woman aged 75 years or older who has two or more independent clinical risk factors for fracture or indicators of low BMD has not previously had her BMD measured, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible.
In deciding between risedronate and etidronate, clinicians and patients need to balance the overall proven effectiveness profile of the drugs against their tolerability and adverse effects in individual patients.
Strontium ranelate is recommended as an alternative treatment option for the primary prevention of osteoporotic fragility fractures in postmenopausal women:
  • who are unable to comply with the special instructions for the administration of alendronate and either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate (as defined below) and
  • who also have a combination of T-score, age and number of independent clinical risk factors for fracture (see below) as indicated in the following table.
T-scores (SD) at (or below) which strontium ranelate is recommended when alendronate and either risedronate or etidronate cannot be taken
Number of independent clinical risk factors for fracture
Age (years)
0
1
2
65–69
N/Aa
-4.5
-4.0
70–74
-4.5
-4.0
-3.5
75 or older
-4.0
-4.0
-3.0
a Treatment with strontium ranelate is not recommended.
Raloxifene is not recommended as a treatment option for the primary prevention of osteoporotic fragility fractures in postmenopausal women.

Independent clinical risk factors

For the purposes of this guidance, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis.

Indicators of low BMD

For the purposes of this guidance, indicators of low BMD are low body mass index (defined as less than 22 kg/m2), medical conditions such as ankylosing spondylitis, Crohn's disease, conditions that result in prolonged immobility, and untreated premature menopauseRheumatoid arthritis is also a medical condition indicative of low BMD..

Intolerance

For the purposes of this guidance, intolerance of alendronate, risedronate or etidronate is defined as persistent upper gastrointestinal disturbance that is sufficiently severe to warrant discontinuation of treatment, and that occurs even though the instructions for administration have been followed correctly.

Primary prevention

For the purposes of this guidance, primary prevention refers to opportunistic identification, during visits to a healthcare professional for any reason, of postmenopausal women who are at risk of osteoporotic fragility fractures and who could benefit from drug treatment. It does not imply a dedicated screening programme.

Women currently receiving treatment

Women who are currently receiving treatment with one of the drugs covered by this guidance, but for whom treatment would not have been recommended according to this guidance, should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

Denosumab

Denosumab is recommended as a treatment option for the primary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures:
  • who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, or have an intolerance of, or a contraindication to, those treatments and
  • who have a combination of T-score, age and number of independent clinical risk factors for fracture (see below) as indicated in the following table.
T-scores (SD) at (or below) which denosumab is recommended when alendronate and either risedronate or etidronate are unsuitable
Number of independent clinical risk factors for fracture
Age (years)
0
1
2
65–69
N/Aa
-4.5
-4.0
70–74
-4.5
-4.0
-3.5
75 or older
-4.0
-4.0
-3.0
a Treatment with denosumab is not recommended.

Independent clinical risk factors

For the purposes of this guidance, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis.

Women currently receiving treatment

People currently receiving denosumab for the primary prevention of osteoporotic fragility fractures who do not meet the criteria specified above should have the option to continue treatment until they and their clinician consider it appropriate to stop.
These recommendations relating to primary prevention of osteoporotic fragility fractures are from denosumab for the prevention of osteoporotic fractures in postmenopausal women (NICE technology appraisal guidance 204).
NICE has written information for the public explaining the guidance on denosumab.

Source guidance

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Secondary prevention of osteoporotic fragility fractures in postmenopausal women

Secondary prevention of osteoporotic fragility fractures in postmenopausal women

Secondary prevention of osteoporotic fragility fractures in postmenopausal women

Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide

This guidance relates only to treatments for the secondary prevention of fragility fractures in postmenopausal women who have osteoporosis and have sustained a clinically apparent osteoporotic fragility fracture. Osteoporosis is defined by a T-score of -2.5 SD or below on DXA scanning (please note: T-score relates to the measurement of BMD using central [hip and/or spine] DXA scanning, and is expressed as the number of SD from peak BMD). However, the diagnosis may be assumed in women aged 75 years or older if the responsible clinician considers a DXA scan to be clinically inappropriate or unfeasible.
This guidance assumes that women who receive treatment have an adequate calcium intake and are vitamin D replete. Unless clinicians are confident that women who receive treatment meet these criteria, calcium and/or vitamin D supplementation should be considered.
This guidance does not cover the following:
  • The use of alendronate, etidronate, risedronate, raloxifene, strontium ranelate or teriparatide for the secondary prevention of osteoporotic fragility fractures in women with normal BMD or osteopenia (that is, women with a T score between -1 and -2.5 SD below peak BMD).
  • The use of these drugs for the secondary prevention of osteoporotic fragility fractures in women who are on long-term systemic corticosteroid treatment.
Alendronate is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women who are confirmed to have osteoporosis (that is, a T-score of -2.5 SD or below). In women aged 75 years or older, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible. When the decision has been made to initiate treatment with alendronate, the preparation prescribed should be chosen on the basis of the lowest acquisition cost available.
Risedronate and etidronate are recommended as alternative treatment options for the secondary prevention of osteoporotic fragility fractures in postmenopausal women:
  • who are unable to comply with the special instructions for the administration of alendronate, or have a contraindication to or are intolerant of alendronate (as defined below) and
  • who also have a combination of T-score, age and number of independent clinical risk factors for fracture (see below) as indicated in the following table.
T-scores (SD) at (or below) which risedronate or etidronate is recommended when alendronate cannot be taken
Number of independent clinical risk factors for fracture
Age (years)
0
1
2
50–54
Treatment with risedronate or etidronate is not recommended.
-3.0
-2.5
55–59
-3.0
-3.0
-2.5
60–64
-3.0
-3.0
-2.5
65–69
-3.0
-2.5
-2.5
70 or older
-2.5
-2.5
-2.5
If a woman aged 75 years or older has not previously had her BMD measured, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible.
In deciding between risedronate and etidronate, clinicians and patients need to balance the overall proven effectiveness profile of the drugs against their tolerability and adverse effects in individual patients.
Strontium ranelate and raloxifene are recommended as alternative treatment options for the secondary prevention of osteoporotic fragility fractures in postmenopausal women:
  • who are unable to comply with the special instructions for the administration of alendronate and either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate (as defined below) and
  • who also have a combination of T-score, age and number of independent clinical risk factors for fracture (see below) as indicated in the following table.
T-scores (SD) at (or below) which strontium ranelate or raloxifene is recommended when alendronate and either risedronate or etidronate cannot be taken
Number of independent clinical risk factors for fracture
Age (years)
0
1
2
50–54
Treatment with raloxifene or strontium ranelate is not recommended.
-3.5
-3.5
55–59
-4.0
-3.5
-3.5
60–64
-4.0
-3.5
-3.5
65–69
-4.0
-3.5
-3.0
70–74
-3.0
-3.0
-2.5
75 or older
-3.0
-2.5
-2.5
If a woman aged 75 years or older who has one or more independent clinical risk factors for fracture or indicators of low BMD has not previously had her BMD measured, a DXA scan may not be required if the responsible clinician considers it to be clinically inappropriate or unfeasible.
For the purposes of this guidance, indicators of low BMD are low body mass index (defined as less than 22 kg/m2), medical conditions such as ankylosing spondylitis, Crohn's disease, conditions that result in prolonged immobility, and untreated premature menopause. Rheumatoid arthritis is also a medical condition indicative of low BMD.
In deciding between strontium ranelate and raloxifene, clinicians and patients need to balance the overall proven effectiveness profile of these drugs against their tolerability and other effects in individual patients.
Teriparatide is recommended as an alternative treatment option for the secondary prevention of osteoporotic fragility fractures in postmenopausal women:
  • who are unable to take alendronate and either risedronate or etidronate, or have a contraindication to or are intolerant of alendronate and either risedronate or etidronate (as defined in below), or who have a contraindication to, or are intolerant of strontium ranelate (as defined in below), or who have had an unsatisfactory response (as defined in below) to treatment with alendronate, risedronate or etidronate and
  • who are 65 years or older and have a T-score of -4.0 SD or below, or a T-score of -3.5 SD or below plus more than two fractures, or who are aged 55–64 years and have a T-score of -4 SD or below plus more than two fractures.

Independent clinical risk factors

For the purposes of this guidance, independent clinical risk factors for fracture are parental history of hip fracture, alcohol intake of 4 or more units per day, and rheumatoid arthritis.

Intolerance

For the purposes of this guidance, intolerance of alendronate, risedronate or etidronate is defined as persistent upper gastrointestinal disturbance that is sufficiently severe to warrant discontinuation of treatment, and that occurs even though the instructions for administration have been followed correctly.
For the purposes of this guidance, intolerance of strontium ranelate is defined as persistent nausea or diarrhoea, either of which warrants discontinuation of treatment.

Unsatisfactory response

For the purposes of this guidance, an unsatisfactory response is defined as occurring when a woman has another fragility fracture despite adhering fully to treatment for 1 year and there is evidence of a decline in BMD below her pre-treatment baseline.

Women currently receiving treatment

Women who are currently receiving treatment with one of the drugs covered by this guidance, but for whom treatment would not have been recommended according to this guidance, should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

Denosumab

Denosumab is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures who are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, or have an intolerance of, or a contraindication to, those treatments.

Women currently receiving treatment

People currently receiving denosumab for the secondary prevention of osteoporotic fragility fractures who do not meet the criteria specified should have the option to continue treatment until they and their clinician consider it appropriate to stop.
These recommendations relating to secondary prevention of osteoporotic fragility fractures are from denosumab for the prevention of osteoporotic fractures in postmenopausal women. (NICE technology appraisal guidance 204).
NICE has written information for the public explaining the guidance on denosumab.

Source guidance

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Treatment of vertebral compression fractures

Treatment of vertebral compression fractures

Treatment of vertebral compression fractures

Percutaneous vertebroplasty, and percutaneous balloon kyphoplasty without stenting, are recommended as options for treating osteoporotic vertebral compression fractures only in people:
  • who have severe ongoing pain after a recent, unhealed vertebral fracture despite optimal pain management and
  • in whom the pain has been confirmed to be at the level of the fracture by physical examination and imaging.
NICE has produced information for the public explaining the guidance on percutaneous vertebroplasty and percutaneous balloon kyphoplasty without stenting.

Implementation tools

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Source guidance

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Patient experience in adult NHS services pathway

View the 'Patient experience in adult NHS services overview' path

Paths in this pathway

Pathway created: August 2012 Last updated: January 2014

Copyright © 2014 National Institute for Health and Care Excellence. All Rights Reserved.

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